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PubMed Journals Articles About "Sunovion Announces Acceptance Review Drug Application Dasotraline" RSS

13:26 EDT 14th August 2018 | BioPortfolio

Sunovion Announces Acceptance Review Drug Application Dasotraline PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Sunovion Announces Acceptance Review Drug Application Dasotraline articles that have been published worldwide.

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Showing "Sunovion Announces Acceptance Review Drug Application Dasotraline" PubMed Articles 1–25 of 32,000+

Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices. Final rule.

The Food and Drug Administration (FDA or we) is amending its regulations on acceptance of data from clinical investigations for medical devices. We are requiring that data submitted from clinical investigations conducted outside the United States intended to support an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a request for De Novo classification, a premarket approval (PMA) application, a product development protocol (PDP) application, or a huma...


Relationship Between the Review Time and Various PMDA Consultations in Recent New Drug Approval Cases in Japan.

It is considered important that the applicants and reviewers communicate well from the development stage and that both mutually understand the development strategy and application contents in conducting the review efficiently after the application is submitted. Therefore, we focus on Pharmaceuticals and Medical Devices Agency (PMDA) consultations from the viewpoint of communication before the application and clarify the issues to consider in the challenge to reduce the review time in terms of the relationsh...

Improving sensory acceptance and physicochemical properties by ultrasound application to restructured cooked ham with salt (NaCl) reduction.

The objective of this research was to study the effects of salt reduction and the application of ultrasound (nominal current of 600 W cm for 10 min) on the physicochemical properties, the microstructure and the sensory acceptance of restructured cooked ham. Four treatments with reduced salt including one with the application of ultrasound (1.5, 1.12, 0.75 and 0.75% salt + ultrasound) were produced. The treatment with 0.75% salt provided a reduction of about 30% in the sodium content. The use of ultras...


Consumer acceptance of cultured meat: A systematic review.

Cultured meat grown in-vitro from animal cells is being developed as a way of addressing many of the ethical and environmental concerns associated with conventional meat production. As commercialisation of this technology appears increasingly feasible, there is growing interest in the research on consumer acceptance of cultured meat. We present a systematic review of the peer-reviewed literature, and synthesize and analyse the findings of 14 empirical studies. We highlight demographic variations in consumer...

Acceptance and Commitment Therapy in cancer: Review of applications and findings.

This study aimed to analyse published studies regarding the usefulness of Acceptance and Commitment Therapy in the treatment of oncological patients. A systematic review of the literature was conducted using the Web of Science, Google Scholar and Dialnet (2000-2016). Nineteen articles fulfilled the inclusion criteria. Those patients who received interventions based on Acceptance and Commitment Therapy showed a better emotional state and quality of life and greater psychological flexibility. Acceptance and C...

Considerations for anti-cancer drug application by single arm trials.

Single arm trial (SAT) was widely used for new drug application (NDA) of novel anti-cancer drugs in recent years. The listing time was greatly shortened by SAT while comparing with randomized controlled trials (RCT). Thus, the companies intended to get NDA through SAT. To encourage innovation and accelerate the developments of anti-cancer agents, we summarize the background and key issues of SAT, discuss the conditions of accepting SAT for NDA, and systematically elaborate the design and principles of SAT i...

Combined use of nanocarriers and physical methods for percutaneous penetration enhancement.

Dermal and transdermal drug delivery (due to its non-invasiveness, avoidance of the first-pass metabolism, controlling the rate of drug input over a prolonged time, etc.) have gained significant acceptance. Several methods are employed to overcome the permeability barrier of the skin, improving drug penetration into/through skin. Among chemical penetration enhancement methods, nanocarriers have been extensively studied. When applied alone, nanocarriers mostly deliver drugs to skin and can be used to treat s...

Poly (amidoamine) (PAMAM) dendrimer mediated delivery of drug and pDNA/siRNA for cancer therapy.

Poly (amidoamine) (PAMAM) dendrimers are well-defined, highly branched macromolecules with numerous active amine groups on the surface. Because of their unique properties, PAMAM dendrimers have steadily grown in popularity in drug delivery, gene therapy, medical imaging and diagnostic application. This review focuses on the recent developments on the application in PAMAM dendrimers as effective carriers for drug and gene (pDNA, siRNA) delivery in cancer therapy, including: a) PAMAM for anticancer drug deliv...

VA Announces Plan to Improve Worst-Performing Medical Centers.

Patient Acceptance of Sustained Glaucoma Treatment Strategies.

To assess patient acceptance of different methods for delivering sustained-release, intraocular pressure (IOP) lowering medications METHODS:: Electronic surveys were administered to 150 patients at two glaucoma clinics. Participants were questioned on their willingness to accept: (1) drug-eluting contact lenses, (2) ring inserts (3) punctal plugs, and (4) sub-conjunctival injections as alternatives to IOP-lowering eye drops based on various success levels. Multivariable logistic regression models determined...

Establishment of an Evaluation Method to Detect Drug Distribution in Hair Follicles.

Development of an appropriate method to evaluate drug disposition or targeting ability in hair follicles (HFs) is urgently needed in order to develop useful pharmaceutical products with pharmacological effects in HFs. In the present study, a cyanoacrylate biopsy (CB) method was used to measure drug disposition in HFs using a model hydrophilic drug, caffeine (CAF), and a lipophilic drug, 4-butylresorcinol (BR), in excised porcine skin. As a result, the height of HF replicas and the recovery ratio decreased w...

Functionalization of graphene family nanomaterials for application in cancer therapy.

Graphene family nanomaterials' (GFN) ability to interact with near-infrared light has propelled their application in cancer photothermal therapy. Furthermore, the graphitic lattice of GFN can adsorb different types of molecules, which has motivated their use in cancer drug delivery. However, the direct application of GFN in cancer therapy is severely hindered by their poor colloidal stability, sub-optimal safety, inefficient tumor uptake and non-selectivity towards cancer cells. To overcome these limitation...

Factors Affecting Consumer Acceptance of an Online Health Information Portal Among Young Internet Users.

Despite the proliferation of health and nursing informatics applications in the past decade, factors influencing consumer acceptance of the applications are not well understood. This study was conducted to investigate factors affecting acceptance of a consumer-used nursing informatics application (ie, online health information portal) within the framework of the Technology Acceptance Model. A cross-sectional study was conducted in which 201 Chinese young adults were invited to participate in usability testi...

Evaluation of preventable adverse drug reactions by implementation of the nationwide network of prospective drug utilization review program in Korea.

A prospective Drug Utilization Review (DUR) program has been implemented in Korea to improve the quality and safety of medication use.

Public Acceptance of Fully Automated Driving: Effects of Social Trust and Risk/Benefit Perceptions.

Automated driving (AD) is one of the most significant technical advances in the transportation industry. Its safety, economic, and environmental benefits cannot be realized if it is not used. To explain, predict, and increase its acceptance, we need to understand how people perceive and why they accept or reject AD technology. Drawing upon the trust heuristic, we tested a psychological model to explain three acceptance measures of fully AD (FAD): general acceptance, willingness to pay (WTP), and behavioral ...

A bibliometric review of drug repurposing.

We have conducted a bibliometric review of drug repurposing by scanning >25 million papers in PubMed and using text-mining methods to gather, count and analyze chemical-disease therapeutic relationships. We find that >60% of the ∼35000 drugs or drug candidates identified in our study have been tried in more than one disease, including 189 drugs that have been tried in >300 diseases each. Whereas in the majority of cases these drugs were applied in therapeutic areas close to their original use, there have ...

Therapeutic Drug Monitoring of Antiepileptic Drugs in Epilepsy: A 2018 Update.

Antiepileptic drugs (AEDs) are the mainstay of epilepsy treatment. Since 1989, 18 new AEDs have been licensed for clinical use and there are now 27 licensed AEDs in total for the treatment of patients with epilepsy. Furthermore, several AEDs are also used for the management of other medical conditions, e.g., pain and bipolar disorder. This has led to an increasingly widespread application of therapeutic drug monitoring (TDM) of AEDs, making AEDs among the most common medications for which TDM is performed. ...

Prevalence of drug use among students in mainland China: A systematic review and meta-analysis for 2003-2013.

In response to calls to reassess and reform international drug policy, we estimated the prevalence of drug use among students in China from 2004 to 2013 through a systematic review and meta-analysis.

Application of in vitro CYP and transporter assays to predict clinical drug-drug interactions.

PRINTING TECHNIQUES: RECENT DEVELOPMENTS IN PHARMACEUTICAL TECHNOLOGY.

In the last few years there has been a huge progress in a development of printing techniques and their application in pharmaceutical sciences and particularly in the pharmaceutical technology. The variety of printing methods makes it necessary to systemize them, explain the principles of operation, and specify the possibilities of their use in pharmaceutical technology. This paper aims to review the printing techniques used in a drug development process. The growing interest in 2D and 3D printing methods re...

An LC-MS/MS method for absolute quantification of nivolumab in human plasma: application to clinical therapeutic drug monitoring.

Nivolumab is a fully humanized IgG4 monoclonal antibody that targets the programmed death-1 (PD-1) receptor, disrupting PD-1-mediated signaling and restoring antitumor immunity. The objective of this study was to develop a nivolumab quantification method using liquid chromatography-tandem mass spectrometry (LC-MS/MS) and to evaluate its application in clinical therapeutic drug monitoring.

Analytical Target Profile: establishment of precision requirements for assay.

Approaches are presented to establish precision (or target measurement uncertainty) requirements to drug substance and drug product assays. They are based on the simple and well-known concept of the normal distribution probability around true content values represented either by manufacturing range limits, or by the manufacturing target (usually 100% label claim). A maximum acceptable precision is derived which allows a defined probability of analytical results within the established acceptance limits of th...

Nanodiamond applications in skin preparations.

The biocompatibility and nontoxicity of nanodiamonds (NDs) in combination with their excellent physical performance have rendered them attractive candidates for biomedical applications. NDs have great potential in drug nanoformulations because of their small size compared with other carbon nanomaterials. They are nontoxic with excellent adsorption properties and can be formulated into skin care products. Even though NDs have shown encouraging potential in skin preparations, only a few studies have reviewed ...

Recent Advances in the Application of Vitamin E TPGS for Drug Delivery.

D-ɑ-tocopheryl polyethylene glycol succinate (Vitamin E TPGS or TPGS) has been approved by FDA as a safe adjuvant and widely used in drug delivery systems. The biological and physicochemical properties of TPGS provide multiple advantages for its applications in drug delivery like high biocompatibility, enhancement of drug solubility, improvement of drug permeation and selective antitumor activity. Notably, TPGS can inhibit the activity of ATP dependent P-glycoprotein and act as a potent excipient for overc...

Designing an intuitive web application for drug discovery scientists.

Here, we discuss how we designed the Open Targets Platform (www.targetvalidation.org), an intuitive application for bench scientists working in early drug discovery. To meet the needs of our users, we applied lean user experience (UX) design methods: we started engaging with users very early and carried out research, design and evaluation activities within an iterative development process. We also emphasize the collaborative nature of applying lean UX design, which we believe is a foundation for success in ...


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